Senior Manager, RA Global Regulatory Strategy, US & Canada - Remote

Overview

The Senior Manager, RA Global Regulatory Strategy, US & Canada position is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development within the Oncology TA.

In Short

• Responsible for regulatory strategy for oncology products in the US and Canada.
• Acts as liaison with FDA, coordinating meetings and submission preparation.
• Independently negotiates and makes decisions on regulatory issues.
• Prepares and reviews regulatory submissions to Health Authorities.
• Implements regulatory strategies based on government regulations.
• Presents regulatory information to cross-functional teams.
• Operates in compliance with regulations and corporate policies.
• Supports commercialization of products meeting regulatory requirements.
• Assists in developing and training staff members.
• Experience in a complex matrix environment is beneficial.

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, or related field.
• 6 years of regulatory or industry-related experience required.
• 2-3 years of experience in pharmaceutical regulatory activities preferred.
• Excellent negotiation and problem-solving skills.
• Effective written and oral communication skills.
• Proven ability to implement regulatory strategies.
• Global regulatory experience is a plus.
• Experience interfacing with regulatory agencies.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off including vacation and sick leave.
• 401(k) plan for eligible employees.
• Participation in short-term and long-term incentive programs.